7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
WALKER FOLDING ADJUSTABLE
FDA 510(k)
FDA Class 1
·Physical Medicine
STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE
FDA 510(k)
FDA Class 2
·Neurology
Trackit T4 EEG Amplifier
FDA 510(k)
FDA Class 2
·Neurology
HOME CHOICEPRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 4, 2012
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 19, 2013
PINN MAR NEUT 36IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·July 22, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021